Neck PainNCT06149442
The Importance of the Number of Incisions in the Effectiveness of Dry Needling
A study testing Dose of five-incisions dry needling technique, Dose of ten-incisions dry needling technique and Dose of fifteen-incisions dry needling technique in people with Neck Pain, run by University of Alcala at 2 sites in Spain.
Trial summary
The dry needling technique is a procedure increasingly used by health professionals. Dry needling consists of the use of a filiform needle to treat musculoskeletal pain. Currently, the mechanisms by which it is an effective technique are not well understood. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Dose of five-incisions dry needling technique, Dose of ten-incisions dry needling technique and Dose of fifteen-incisions dry needling technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSpain
- Study dates
- 4 Dec 2023to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nonspecific mechanical neck pain for more than 3 months.
- Neck pain of at least VAS 5/10.
- Reproduction of pain and symptoms subjects on palpation.
- Pain on passive stretching of the muscle.
Who cannot join
- Subjects with previous surgical intervention.
- Subjects undergoing other intervention (rehabilitation/medication).
- Positive findings that raise suspicion of cervical radiculopathy:
- Subjects diagnosed: degenerative arthropathies, inflammatory, systemic conditions (fibromyalgia).
- Cardiovascular diseases.
- Whiplash or whiplash.
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- Belenophobia.
- Dizziness and vertigo.
- Pregnant.
- Thyroid disorders.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Centro Investigación Fisioterapia y Dolor
Alcalá de Henares, Madrid, 28805
Physiotherapy and Pain Institute
Alcalá de Henares, Madrid, 28805
About this study
Official title: Effectiveness of the Dry Needling Technique According to the Number of Incisions in the Treatment of Neck Pain
The dry needling technique is a procedure increasingly used by health professionals.
Dry needling consists of the use of a filiform needle to treat musculoskeletal pain. Currently, the mechanisms by which it is an effective technique are not well understood. One of the aspects not yet evaluated is the best dose in terms of the number of times it is necessary to insert the needle into the patient to achieve the best result.
This research work aims to assess which treatment obtains the best results in the management of patients with chronic neck pain.
Read the detailed description
With the objective of demonstrating how the dose used during the application of the dry needling technique is related to the effectiveness of the treatment, we have designed a study where three different doses of the dry needling technique for the treatment of myofascial trigger points will be compared in the upper trapezius muscle in participants with neck pain.
Randomly, the participants will be distributed to each of the treatment groups and we will measure how the effectiveness of each of the applied doses determines the result of the application of the dry needling technique in the treatment of neck pain.
- Conditions
- Neck Pain
- Being tested
- Dose of five-incisions dry needling technique, Dose of ten-incisions dry needling technique, Dose of fifteen-incisions dry needling technique
- Keywords
- dry needling, myofascial trigger point
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose of five-incisions dry needling techniqueOther
Once we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (five incisions).
Dose of ten-incisions dry needling techniqueOther
Once we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (ten incisions).
Dose of fifteen-incisions dry needling techniqueOther
Once we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (fifteen incisions).
| Study group | Role | What they receive |
|---|---|---|
| Dose of five muscle incisions | Experimental | Subjects treated in this group will receive an in-out technique with a dosage of five incisions in the myofascial trigger point of the levator scapulae muscle. Receives: Other: Dose of five-incisions dry needling technique |
| Dose of ten muscle incisions | Experimental | Subjects treated in this group will receive an in-out technique with a dosage of ten incisions in the myofascial trigger point of the levator scapulae muscle. Receives: Other: Dose of ten-incisions dry needling technique |
| Dose of fifteen muscle incisions | Experimental | Subjects treated in this group will receive an in-out technique with a dosage of fifteen incisions in the myofascial trigger point of the levator scapulae muscle. Receives: Other: Dose of fifteen-incisions dry needling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain
Visual Analog Scale (VAS). VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. It is a straight horizontal line of fixed length, usually 100 mm where 0 is no pain and 10 is the worst possible pain.
Measured: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
Secondary outcomes (4)
Disability (Neck disability index)
This questionnaire has been designed to give us information as to how your neck pain has affected your ability to manage in everyday life. It´s value ranges from 0 to 10 to 50 points, where 0 is the absence of disability and 50 is the highest degree of disability.
Measured: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
Pain catastrophizing
Pain Catastrophizing Scale (PCS). The PCS is a 13-item instrumen that task participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS total scores range from 0 - 52. 0 is the best result and 52 is the worst result.
Measured: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
kinesiophobia
The Tampa Scale of Kinesiophobia (TSK) describe patient circumstances characterised by an "excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability to painful injury or reinjury. The TSK is a 17 item assessment checklist.The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Measured: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
The Global Rating of Change (GRoC)
It's a scale that assesses whether the patient condition has gotten worse, better, or stayed
Measured: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start4 Dec 2023
- Primary completion20 Jan 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Daniel Pecos-Martin, PhD, Study director, Alcalá University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149442
- Sponsor's protocol ID
- CEIM/2022/1/008
- Status last verified
- Aug 2026
- First submitted
- 20 Nov 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Dry Needling Technique According to the Number of Incisions in the Treatment of Neck Pain
- ClinicalTrials.gov ID
- NCT06149442
- Acronym / sponsor ID
- CEIM/2022/1/008
- Conditions
- Neck Pain
- Keywords
- dry needling, myofascial trigger point
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The dry needling technique is a procedure increasingly used by health professionals.
Dry needling consists of the use of a filiform needle to treat musculoskeletal pain. Currently, the mechanisms by which it is an effective technique are not well understood. One of the aspects not yet evaluated is the best dose in terms of the number of times it is necessary to insert the needle into the patient to achieve the best result.
This research work aims to assess which treatment obtains the best results in the management of patients with chronic neck pain.
Detailed description
With the objective of demonstrating how the dose used during the application of the dry needling technique is related to the effectiveness of the treatment, we have designed a study where three different doses of the dry needling technique for the treatment of myofascial trigger points will be compared in the upper trapezius muscle in participants with neck pain.
Randomly, the participants will be distributed to each of the treatment groups and we will measure how the effectiveness of each of the applied doses determines the result of the application of the dry needling technique in the treatment of neck pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose of five muscle incisions | Experimental | Other: Dose of five-incisions dry needling techniqueSubjects treated in this group will receive an in-out technique with a dosage of five incisions in the myofascial trigger point of the levator scapulae muscle. |
| Dose of ten muscle incisions | Experimental | Other: Dose of ten-incisions dry needling techniqueSubjects treated in this group will receive an in-out technique with a dosage of ten incisions in the myofascial trigger point of the levator scapulae muscle. |
| Dose of fifteen muscle incisions | Experimental | Other: Dose of fifteen-incisions dry needling techniqueSubjects treated in this group will receive an in-out technique with a dosage of fifteen incisions in the myofascial trigger point of the levator scapulae muscle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Nonspecific mechanical neck pain for more than 3 months.
- Neck pain of at least VAS 5/10.
- Reproduction of pain and symptoms subjects on palpation.
- Pain on passive stretching of the muscle.
Key exclusion criteria (10 listed)
- Subjects with previous surgical intervention.
- Subjects undergoing other intervention (rehabilitation/medication).
- Positive findings that raise suspicion of cervical radiculopathy:
- Subjects diagnosed: degenerative arthropathies, inflammatory, systemic conditions (fibromyalgia).
- Cardiovascular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose of five-incisions dry needling techniqueOnce we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (five incisions). | Other | Dose of five muscle incisions |
| Dose of ten-incisions dry needling techniqueOnce we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (ten incisions). | Other | Dose of ten muscle incisions |
| Dose of fifteen-incisions dry needling techniqueOnce we have assessed the existence of a myofascial trigger point in the levator scapulae muscle, and while the subject is in lateral decubitus on the same side, with a forceps palpation, we apply a rapid in /out dry needling technique (fifteen incisions). | Other | Dose of fifteen muscle incisions |
Primary outcome
Neck pain
Time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
Visual Analog Scale (VAS). VAS is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. It is a straight horizontal line of fixed length, usually 100 mm where 0 is no pain and 10 is the worst possible pain.
4 secondary outcomes
Disability (Neck disability index)
Time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
Pain catastrophizing
Time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
kinesiophobia
Time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
The Global Rating of Change (GRoC)
Time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Pecos-Martin, PhD study director
Alcalá University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dose of five-incisions dry needling technique, Dose of ten-incisions dry needling technique and Dose of fifteen-incisions dry needling technique in people with Neck Pain, run by University of Alcala at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain (time frame: Change From Baseline in Pain Scores on the Visual Analog Scale at three month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.